Influence of Intestinal Transporter Genetic Variants on the Bioavailability of Gabapentin

This study is currently recruiting participants.

Verified by University of California, San Francisco, September 2005

First Received: September 14, 2005 No Changes Posted

Sponsor:	University of California, San Francisco
Information provided by:	University of California, San Francisco
ClinicalTrials.gov Identifier:	NCT00187707

Purpose

The current study is part of a large multi-investigator grant to look at the pharmacogenetics of a number of membrane transporters. Previously, we have recruited a cohort of healthy volunteers (Studies of Pharmacogenetics in Ethnically-diverse Populations, or SOPHIE) and have resequenced the coding region of a number of membrane transporter genes to identify genetic polymorphisms in these genes. We plan to take a genotype-to-phenotype approach to study the influence of specific polymorphisms in the intestinal transporters, such as the novel organic cation transporters 1 and 2 (OCTN1 and OCTN2) genes on the bioavailabilty of gabapentin in healthy subjects. Eligible subjects will have a single inpatient study visit, during which they will take a single dose of gabapentin, and provide blood and urine samples over the course of 36 hours (5 terminal elimination gabapentin half-lives) for pharmacokinetic analysis.

Condition	Intervention
Healthy Volunteer	Drug: Gabapentin

Study Type:	Interventional
Study Design:	Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Pharmacokinetics Study
Official Title:	Influence of Intestinal Transporter Genetic Variants on the Bioavailability of Gabapentin

Resource links provided by NLM:

Drug Information available for: Gabapentin

U.S. FDA Resources

Further study details as provided by University of California, San Francisco:

Estimated Enrollment:	30
Study Start Date:	September 2005

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Subjects must have previously participated in the "SOPHIE" study.
Subjects will be between the ages of 18 and 40 years old
Subjects will have been selected as healthy by medical history questionnaire and screening blood work (CBC, Comprehensive Metabolic panel).
Subjects will be taking no regular medications and will have normal renal function.

Exclusion Criteria:

Pregnant
Have a new history indicating they are no longer healthy; Individuals with anemia (hemoglobin < 12 g/dL), an elevation in liver enzymes to higher than double the respective normal value, or elevated creatinine concentrations (males ≥ 1.5 mg/dL, females ≥ 1.4 mg/dL), will be excluded.
Taking a medication that could confound study results
Do not consent to participate in the study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00187707

Contacts

Contact: Chaline Brown, PharmD

415-476-6756

brownc@pharmacy.ucsf.edu

Locations

United States, California
San Francisco General Hospital	Recruiting
San Francisco, California, United States, 94143
Contact: Chaline Brown, PharmD 415-476-6756 brownc@pharmacy.ucsf.edu

Sponsors and Collaborators

University of California, San Francisco

Investigators

Principal Investigator:

Kathleen Giacomini, PhD

University of California, San Francisco

More Information

No publications provided

Study ID Numbers:	1003
Study First Received:	September 14, 2005
Last Updated:	September 14, 2005
ClinicalTrials.gov Identifier:	NCT00187707 History of Changes
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Neurotransmitter Agents
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Gabapentin
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Antiparkinson Agents
Calcium Channel Blockers
Excitatory Amino Acid Agents
Cardiovascular Agents

Antimanic Agents
Pharmacologic Actions
Membrane Transport Modulators
Sensory System Agents
Therapeutic Uses
Anti-Anxiety Agents
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents
Anticonvulsants
Excitatory Amino Acid Antagonists

ClinicalTrials.gov processed this record on February 08, 2010